valacyclovir

Generic: valacyclovir

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name valacyclovir
Generic Name valacyclovir
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

valacyclovir hydrochloride 500 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-613
Product ID 62135-613_459d28fe-0458-21de-e063-6394a90a6e87
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209553
Listing Expiration 2026-12-31
Marketing Start 2018-10-01

Pharmacologic Class

Classes
dna polymerase inhibitors [moa] herpes simplex virus nucleoside analog dna polymerase inhibitor [epc] herpes zoster virus nucleoside analog dna polymerase inhibitor [epc] herpesvirus nucleoside analog dna polymerase inhibitor [epc] nucleoside analog [ext]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135613
Hyphenated Format 62135-613

Supplemental Identifiers

RxCUI
313564 313565
UPC
0362135613303 0362135614300 0362135613907 0362135614904
UNII
G447S0T1VC

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name valacyclovir (source: ndc)
Generic Name valacyclovir (source: ndc)
Application Number ANDA209553 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (62135-613-30)
  • 90 TABLET in 1 BOTTLE (62135-613-90)
source: ndc

Packages (2)

62135-613-30 30 TABLET in 1 BOTTLE (62135-613-30) 62135-613-90 90 TABLET in 1 BOTTLE (62135-613-90)

Ingredients (1)

valacyclovir hydrochloride (500 mg/1)

Linked Drug Pages (1)

Valacyclovir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "459d28fe-0458-21de-e063-6394a90a6e87", "openfda": {"upc": ["0362135613303", "0362135614300", "0362135613907", "0362135614904"], "unii": ["G447S0T1VC"], "rxcui": ["313564", "313565"], "spl_set_id": ["e59f15d0-c32a-4848-bdd5-fc2542e561c0"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (62135-613-30)", "package_ndc": "62135-613-30", "marketing_start_date": "20230621"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-613-90)", "package_ndc": "62135-613-90", "marketing_start_date": "20230621"}], "brand_name": "Valacyclovir", "product_id": "62135-613_459d28fe-0458-21de-e063-6394a90a6e87", "dosage_form": "TABLET", "pharm_class": ["DNA Polymerase Inhibitors [MoA]", "Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Nucleoside Analog [EXT]"], "product_ndc": "62135-613", "generic_name": "Valacyclovir", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Valacyclovir", "active_ingredients": [{"name": "VALACYCLOVIR HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA209553", "marketing_category": "ANDA", "marketing_start_date": "20181001", "listing_expiration_date": "20261231"}